Status:
COMPLETED
The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Dairy Organization (NZO)
Conditions:
Healthy
Ileostomy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
A controlled dietary intervention study will be carried out based on the stable isotope method the investigators have developed to quantify both the absorption of beta-carotene and its bioconversion t...
Eligibility Criteria
Inclusion
- Men and women between 18 and 75 years old
- Body mass index (BMI) between 18 and 30 kg/m2
- Willing to consume the controlled diet and not consume other food items
- Willing to consume the capsules every day
- Having a functional ileostomy (output \<2 L/d)
- Relatively good medical, nutritional and health status
Exclusion
- Diseases which disturb normal digestion and absorption
- Use of (oral) drugs suspected of interfering with fat-soluble vitamin absorption
- Excessive alcohol consumption (\>30 g/d)
- Consumption of vitamin or carotenoid supplements 6 weeks before and during the study
- Not too low or high levels of serum beta-carotene and retinol
- Normal hemoglobin, hemocytometry, creatinine, ALAT, alkaline phosphatase, and cholesterol blood values (compared with laboratory references)
- Pregnancy
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00128804
Start Date
July 1 2004
End Date
October 1 2004
Last Update
August 29 2005
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500HB